Exploring the Clinical Applications of Virtual Reality in Healthcare

Background:

While most people think of virtual reality as a source of entertainment, there are potential clinical applications of virtual reality. In this article, we will explore some of the most promising clinical applications of VR, the data from peer-reviewed studies with regards to the effectiveness of VR in these clinical settings, the FDA landscape in the clinical VR space, and payer reimbursement for VR clinical solutions. Finally, we will end with a prediction as to whether VR clinical solutions will get mainstream adoption in healthcare. Please note that in this article I focus on the patient facing applications of VR in healthcare. There are another group of applications on provider side, from provider training (most notably in surgery) to radiology applications, that are not discussed in this article. If there is sufficient interest, I can write a companion piece to this article exploring those healthcare applications of VR.

Psychiatric Applications of Virtual Reality:

The psychiatric applications of virtual reality revolve around virtual reality exposure therapy (VRET). VRET involves the use of VR to create realistic, immersive environments used for the purpose of providing therapeutic benefit to patients. The two principle psychiatric applications of VRET are below:

1. Phobia and Anxiety Disorders: Patients can face their fears in a controlled setting, gradually exposing them to their anxiety triggers. The hypothesis is VRET can help treat conditions like social anxiety disorder (SAD), agoraphobia, claustrophobia, acrophobia (fear of heights), arachnophobia (fear of spiders), and more.
2. Post-Traumatic Stress Disorder (PTSD): Patients are gradually exposed to trauma-related stimuli, allowing them to confront and process their trauma in a safe environment.

When assessing the clinical validity of VRET, it is important to have a lay of the land for the gold standard treatment(s). This allows us to compare VRET against these interventions. Most therapies include both pharmaceutical and non-pharmaceutical interventions. For the sake of this article, we will focus on the non-pharmaceutical interventions as the gold-standards of comparison, as presumably that would be the piece of the treatment plan VRET would be augmenting/acting as an alternative to. Phobias/anxiety and PTSD mainstay treatment both involve use of cognitive behavioral therapy (CBT). Treatment of phobias also frequently involve the addition of in-vivo exposure therapy. This involves gradually exposing the patient in a controlled manner to whatever stressor is causing the patient anxiety. In-vivo means the exposure is real life exposure. For example, if a patient has a public speaking phobia, the in-vivo exposure therapy would mean exposing the patient gradually to public speaking. For PTSD, since there are usually specific extreme events leading to the patient having PTSD, and since these events are often hard to introduce in a controlled manner, imagination therapy in which the patient imagines the stimulus is often employed.

VRET has undergone clinical validation studies, and there have been systematic reviews with corresponding meta-analysis studies . A combined effort from Baylor University, UT Austin, and the San Francisco VA conducted a meta-analysis on 30 studies that investigated the effectiveness of VRET [1]. VRET versus both placebo and in-vivo therapy for specific phobias, SAD, panic disorder, and PTSD was studied. They reported their findings in terms of effect size. When compared to placebo, a small effect size means that VRET performed comparably to placebo. When compared to in-vivo, a small effect size means VRET performed comparably to the gold-standard in-vivo therapy.

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[1] A systematic review with a meta-analysis is a study in which the author(s) aggregate other studies, combine data from these studies, and analyze the results. The benefits of these studies are you get a more robust data set, and can come to a conclusion if there are studies with competing findings. The downside of these studies is often you are stuck trying to combine heterogenous data sets.

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So the findings that most support VRET would be a large effect size when compared to placebo, and a small effect size compared to in-vivo. The below chart has the study findings:

It appears that VRET is particularly good for specific phobias and SAD. While it is effective for panic disorders, the evidence to support the use of VRET is not quite as robust. While VRET performed better than placebo for PTSD patients, it does not appear to perform as well in this meta-analysis as the other applications of VRET, and evidence when compared to a traditional treatment arm is lacking. Researchers from the Amsterdam University, an institution that conducts a significant amount of VR related research, conducted a meta-analysis specifically on the applications of VRET in treating PTSD patients. They came to similar conclusions: that while VRET outperforms placebo, the studies are to heterogenous, and often not of sufficient quality to make any definite conclusions [2].

Pain Management Applications of Virtual Reality:

Acute Pain Management

VR for acute pain management is mainly used immediately before or after surgeries and medical procedures. It is used for two proposes in this context:

1. Distraction therapy: The immersive nature of VR provides a compelling distraction, diverting the patient's attention away from the pain and discomfort.
2. Pre-operative anxiety reduction: Surgery often induces anxiety. VR can be used pre-operatively to calm patients, guiding them through relaxing virtual environments or educating them about the procedure in a less intimidating manner.

The literature demonstrated a mixed, but ultimately favorable picture for the use of VR for distraction therapy and anxiety reduction in acute pain patients. A meta-analysis of 11 studies with a combined patient count of 400 patients demonstrated a statistically significant pain reduction in burn patients [3]. AppliedVR, one of the main players in the VR for pain management space, partnered with the Cedar Sinai, to conduct a pilot study for the use of VR for pain reduction. The study had 120 hospitalized subjects (61 VR; 59 control). The study posted results in favor of the use of VR therapy, but the results had a large standard deviation, which limits the insights that can be gained from this study [4]. Researchers from the University of Amsterdam and various regional hospitals investigated the effectiveness VR therapy on preoperative pain control and anxiety in 191 children. VR therapy was compared against a control group receiving care as usual (CAU). Outcomes related to pain included self-reported and observed pain, and the need for rescue analgesia. Researchers found in children undergoing elective day care surgery, VRE did not have a beneficial effect on pain above CAU. However, after more painful surgery, children in the VRE group needed rescue analgesia significantly less often [5].

Chronic Pain Management

VR for chronic pain management involves focusing the patient’s mind on a calming virtual environment, often with a narrator’s voice, to guide the patient through a breathing exercise, or progressive muscle relation techniques [6]. VR can also help change the way patients perceive their pain. It can be used to provide visual metaphors for pain, allowing patients to externalize and manipulate their symptoms in the virtual world. This process can help patients feel more control over their pain, reducing its intensity.

There are peer-reviewed clinical investigations in the application of VR in this area. The literature of the effectiveness on chronic pain reduction demonstrates mixed results. The National Institute of Health (NIH) sponsored a meta-analysis to analyze if VR could be used to lower pain and anxiety in patients with solid malignant tumors. Thirteen manuscripts ended up meeting inclusion criteria, but only five of the supporting studies assessed VR for the purpose of pain control (the rest of the supporting studies investigated VR as an anxiety reduction tool). The pooled patient count among these five studies was 241. Three of the five studies demonstrated a statistically significant improvement in pain symptoms [7]. Loma Linda University did a meta-analysis of VR therapy in patients with spinal cord injury (SCI) associated neuropathic pain. They ultimately included and analyzed nine studies with a total patient count of 150. The supporting studies often used audio guided imagery as the control intervention. They found that overall VR outperformed the control interventions, but the researchers called into question the quality of the studies they found [8]. One systematic review with meta-analysis did show a statistically significant benefit for VR therapy being used to treat fibromyalgia associated pain. The combined patient pool was 267 patients. However, like the Loma Linda systematic review, the authors called into question the quality of their supporting studies [9].

AppliedVR has recently published the results of their feasibility studies for both fibromyalgia and chronic back pain. They posted statistically positive results against audio-only therapy for both of their studies [10, 11].

Applications of VR in Patients with Neurological Pathologies/Deficits:

The main neurological application of VR therapy is an exercise program tailored to a neurological deficit and/or pathology. The most common applications are with patients with movement disorders or post-stroke patients. In addition to being assigned an exercise program geared towards treatment, the accelerometers in the VR controllers can monitor neurological movement metrics such as tremors. This allows the patient’s care team to assess how the patient is responding to both the exercise program, and the pharmacological interventions.

The largest relevant primary research  study that I found was a co-lead multi-center study published in the Lancet. Three-hundred-and-two high fall-risk patients with varied motor and cognitive deficits across five clinical centers were enrolled. Researchers compared VR enhanced treadmill exercise programs versus treadmill programs alone. The primary outcome was the incident rate of falls during the 6 months after the end of training. The investigators found the incident rate of falls was lower in the treadmill training plus VR group than in the treadmill training alone group (incident rate ratio  0.58, 95% CI 0.36-0.96; p=0.033). Of note, although this study offers evidence for the effectiveness of VR exercise programs, the focus is on fall reduction opposed to rehabilitation towards any one neurological pathology.

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[2] Primary research is when researchers directly work with patients or conduct laboratory bench work. This contrasts with secondary research in which the investigators are researching and analyzing primary research that has already been done. The systematic reviews I referenced earlier are an example of secondary research.

[3] The Incident Rate Ratio (IRR) is a way of comparing how often something happens in two different groups (for example: a ratio of how many people get the flu in a group that got a flu vaccine versus a group who didn’t get the vaccine).

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There was a moderate amount of research available specifically investigating the effectiveness of VR rehabilitation programs for post-stroke patients. Researchers from Ohio State University conducted a systematic review with a corresponding meta-analysis on 38 studies. The supporting studies used validated performance scoring systems for post-stroke patients, such as the Fugl-Meyer assessment tool. The systematic review found that VR centric rehabilitation programs were non-inferior to conventional rehabilitation programs [12]. A meta-analysis of 260 patients across nine studies from researchers from the University of Nebraska Medical Center similarly found non-inferiority of VR based post-stroke rehabilitation interventions [13]. In full disclosure, the above systematic reviews were published in journals with lower impact factors  than I would like, but I reviewed the methodology, and the methodology appeared sound. On the primary research front, Ability Labs, a well-respected neurotechnology research institution, co-sponsored a pilot study with UNC at Chapel Hill. Fifteen participants underwent a VR post-stroke rehabilitation therapy program versus a standard home exercise program. The objective measure was arm displacement. The authors found the VR program was statistically non-inferior to the home exercise program [14].

There is also research available for the applications of VR exercise programs for other neurological diseases. A systematic review with a meta-analysis of 858 multiple sclerosis patients across 19 randomized controlled trials (RCTs) found that VR based therapy both improved balance and posture, but not gait speed (Cortés-Pérez et al. 2023 [15]). For Parkinson’s disease, a systematic review with a meta-analysis examined how patients responded to a VR enhanced exercise program versus traditional exercise programs. The meta-analysis included fourteen RCTs with a pooled patient group of 524 patients. The results indicated that VR-based rehabilitation improved balance function, as measured by using the Berg balance scale (BBS) [16].

The above studies are just a sample of the research available for the applications of VR enhanced exercise programs for patients with neurological deficits. Although the above research would suggest the validation of both VR based post-stroke rehabilitation programs, and VR exercise programs for patients with movement disorders, more comprehensive studies are needed. Even in instances of systematic reviews with a meta-analysis, most of the supporting studies are smaller pilot studies. However, the initial results are promising.

FDA Landscape:

The FDA has authorized marketing of some VR devices through 510(k) clearances, De Novo requests, or premarket approval [17]. Many of these devices are more provider facing, such as in the realm of radiology or surgical visualization. AppliedVR received permission from the FDA to market AppliedVR’s chronic lower back pain solution via the FDA De Novo premarket pathway [18]. Penumbra received a 510(k) exception to market their exercise rehabilitation platform [19]. They also have CE clearance. XRHealth has registered its clinical VR applications with the FDA [20]. However, at the time of the publication of this article, they have not received any of the approvals or exceptions listed above.

Reimbursement:

AppliedVR just recently became one of the first companies to be approved for payer (insurance) reimbursement [21]. They were able to be approved by being classified as durable medical equipment. This is technically the same category that wheelchairs, canes, and other medical equipment is reimbursed. Although AppliedVR got approved for payer DME reimbursement, there are still a lot of questions pending:

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[4] Impact Factor is considered to be a metric of a journal’s importance in the research community. Mathematically it is calculated based on how often a journal is cited. When evaluating a research article, looking at the impact factor of the journal it is published in is not the end all, be all by any means. And it can be gamed by a publication. But it is one of many metrics to pay attention to when evaluating research articles.

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1. The rate of reimbursement: Generally the rates of reimbursement for insurance companies are set by CME. Insurance companies either directly use or peg their reimbursement rate as a multiple to the rate that CME sets. Although AppliedVR has been approved for reimbursement, at the time of the publication of this article, a rate has not been set.
2. Will they be approved for reoccurring payments, or only a one-time lump sum payment. Both models exist with DME reimbursement, as some DME is rented, and some is owned.  A justification could be made for either case. Payers could argue that it should be a lump sum payment, as only the actual VR hardware (the headset) is the piece of DME. AppliedVR will likely try to justify that the software is also part of the DME package, and hence a rental fee should be paid, ensuring reoccurring revenue.
3. Right now AppliedVR is only approved for DME reimbursement for pain management. It is yet to be seen if they can be approved for DME reimbursement for other clinical applications of VR. However, their initial DME approval is certainly a good sign of further DME approvals to come.

XRHealth got approved for Medicare reimbursement for remote therapy monitoring (RTM). RTM is narrow in the body systems it can be applied to, specifically monitoring musculoskeletal and respiratory systems. But it is broad in the type of data that can be collected for billing purposes, including subjective data like pain scoring [22]. Below is a breakdown of reimbursement codes for RTM and the associated CMS reimbursement rates [23].

Another pathway to consider for reimbursement for VR therapy is remote patient monitoring (RPM). RPM is broader in the conditions/body systems it can be applied to, but more narrow in the data that can be collected. RPM traditionally involves measuring only objective data, like vital signs (heart rate, respiratory rate, ect). An example of how RPM could be utilized in the context of VR is by measuring heart rate variety (HRV). HRV is a metric that has a correlation with psychological stress [24, 25]. If the patient wore an Apple Watch, or took a daily measurement with their smartphone or a smart scale, this data could be collected. The treatment team could then analyze how HRV was responding to the VR treatment. In addition to being an objective metric the treatment team could consider, this would allow for RPM billing. It should be noted that to bill for RPM, you must collect data 16/30 calendar days, and the data must be transmitted directly from the device (ie a patient telling you what their Apple Watch displayed won’t fly) [26]. To my knowledge, no clinical VR strategy has utilized the above RPM strategy.

Below is the CMS reimbursement rates for RPM [27]. Note: you can’t double bill for both RPM and RTM for the same condition for the same patient [22].

For short term applications, like acute pain management, VR companies would likely rent their solution to hospital institutions so they could have reoccurring income. The hospital institutions would likely bill insurance payers with one-off reimbursement codes, but presumably they would be able do this consistently (or so the VR companies would argue).

Final Assessment – Will VR Therapy Catch On:

There are some healthcare technologies I am bullish on. For example, see my article on remote photothermography, which is a way to measure vital signs by simply looking into your smart phone camera (see previous article I wrote here: blog.victech.com/a-new-tech-helping-enable-telemedicine) [28]. I believe this will be a part of every virtual healthcare encounter once the technology matures.

VR therapy is a bit more debatable. We are hardwired to be sensitive to anything on our face, and evolutionarily evolved to not like our peripheral field of vision obstructed. However, there are some compelling initial clinical results. Also, the technology, including the hardware, is continuing to evolve, and become less obstructive, and more lightweight. My personal prediction is there will be a modest, yet sustainable cohort of technology forward patients/physicians that embrace this technology. This will allow small to midsized healthtech companies to have a sustainable business model. The clinical VR focused companies that will be the most successful will likely be those that can capture reoccurring revenue, and make use of the existing payer reimbursement codes. I have my doubts the next Apple will come out of this space. However, if companies like XRHealth could further validate their solutions, and offer a profit-sharing program with outpatient medical centers, that could be a strong offering.

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Disclaimer:

ChatGPT was utilized to aid in the writing of this article. However, the vast majority of the article was written manually by the author, and all references were found and analyzed directly by the author.

References

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